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510(k) Data Aggregation

    K Number
    K080275
    Device Name
    NPD 1000 NEGATIVE PRESSURE WOUND THERAPY SYSTEM
    Manufacturer
    IASIS MEDICAL, INC.
    Date Cleared
    2008-10-09

    (251 days)

    Product Code
    OMP
    Regulation Number
    878.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    IASIS MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NPD 1000 Negative Pressure Wound Therapy System is a portable, low-powered, battery-operated suction pump intended for the application of suction to remove a small amount of fluid from the wound bed including wound exudate and infectious material which may promote wound healing.
    Device Description
    The NPD 1000 Negative Pressure Wound Therapy System includes a small, portable, low powered, battery operated electromechanical pump used with an accessory wound dressing. The system uses controlled negative pressure (vacuum) to remove exudates, which may promote wound healing.
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